← Product Code [DQX](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX) · K961107 # B. BRAUN GUIDEWIRES (K961107) _B.Braun Medical, Inc. · DQX · Oct 1, 1996 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K961107 ## Device Facts - **Applicant:** B.Braun Medical, Inc. - **Product Code:** [DQX](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX.md) - **Decision Date:** Oct 1, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.1330 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Indications for Use The Braun Guidewire is intended to fit inside a catheter for the purpose of directing the catheter through a blood vessel. These catheters may be used for PTCA and PTA procedures. These guidewires are not intended for use for cerebral, reproductive, or neurological procedures. ## Device Story Steerable, shapeable guidewire; used to direct catheters through blood vessels during PTCA/PTA procedures. Available in various diameters, stiffnesses, and lengths. Extendible versions feature proximal attachment for extension wire; allows intravascular device exchange while maintaining distal position. Extension wire is removable; restores original length/functionality. Used by clinicians in interventional settings. ## Clinical Evidence Bench testing only. ## Technological Characteristics Steerable, shapeable guidewire; available in multiple diameters, lengths, and stiffnesses. Features proximal attachment mechanism for extension wire compatibility. Mechanical device; no energy source or software. ## Regulatory Identification A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel. ## Special Controls *Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. ## Predicate Devices - ACS Guidewires ([K852123](/device/K852123.md), [K852354](/device/K852354.md), [K854830](/device/K854830.md), [K861574](/device/K861574.md), [K861765](/device/K861765.md), [K862360](/device/K862360.md), [K864585](/device/K864585.md), [K872220](/device/K872220.md), [K874202](/device/K874202.md), [K874776](/device/K874776.md), [K881787](/device/K881787.md), [K881897](/device/K881897.md), [K884262](/device/K884262.md), [K884895](/device/K884895.md), [K902755](/device/K902755.md), [K905502](/device/K905502.md), [K913328](/device/K913328.md), [K913631](/device/K913631.md), [K915723](/device/K915723.md), [K925381](/device/K925381.md), [K934602](/device/K934602.md), [K942066](/device/K942066.md), [K950156](/device/K950156.md)) - Target Guidewires ([K884198](/device/K884198.md), [K922912](/device/K922912.md), [K914032](/device/K914032.md)) - USCI Guidewires ([K924009](/device/K924009.md), [K933466](/device/K933466.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K961107 OCT 1 1996 ## II. SUMMARY OF SAFETY AND EFFECTIVENESS Applicant Name & Address: B. Braun Medical Inc., Cardiovascular Division 824 Twelfth Avenue Bethlehem, Pa 18018 Contact: Mark Alsberge, Regulatory Affairs Manager Date Prepared: June 21, 1996 Common or Usual Name: B. Braun Guidewires Device Classification Name: Wire, Guide, Catheter Substantial Equivalence: ACS Guidewires-- K852123, K852354, K854830, K861574, K861765, K862360, K864585, K872220, K874202, K874776, K881787, K881897, K884262, K884895, K902755, K905502, K913328, K913631, K915723, K925381, K934602, K942066 / or K950156 Target Guidewires--K884198, K922912 / or K914032 USCI Guidewires--K924009 / or K933466 Guidewire Device Description: The Braun Guidewire is a steerable, shapeable guidewire. The guidewire is available in a variety of diameters, stiffnesses, and lengths. Certain sizes are extendible to exchange lengths. Extendible guidewires have an attachment at the proximal end of the guidewire which is adapted to receive a Braun Guidewire extension wire. Extending the guidewire enables exchange of intravascular devices while maintaining distal guidewire position. The extension is removable and permits the guidewire to be returned to its original length and functionality. Extension Wire Device Description: The Braun Guidewire extension wire is available in sizes compatible with Braun Guidewire extendible guidewires. The distal end of the extension is adapted to engage the proximal end of the guidewire enabling exchange of intravascular devices while maintaining distal guidewire position. The extension is removable and permits the guidewire to be returned to its original length and functionality. Statement of Intended Use: The Braun Guidewire is intended to fit inside a catheter for the purpose of directing the catheter through a blood vessel. These catheters may be used for PTCA and PTA procedures. These guidewires are not intended for use for cerebral, reproductive, or neurological procedures. --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K961107](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K961107) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com